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TOP 5 HEALTH LAWS AND POLICY UPDATES

The Department of Pharmaceuticals (DoP) has extended the deadline for filing a self-declaration under the Uniform Code for Pharmaceutical Marketing Practices, 2024 (UCPMP) to July 31st, 2024. The prior date for filing the self-declaration was June 30th, 2024.
Source: bit.ly/4coX09h

The Central Drugs Standard Control Organization (CDSCO is considering making the international nomenclature of cosmetic ingredients (INCI) mandatory on all cosmetic product labels to improve transparency and identification. The unified INCI method will help customers understand product compositions while assisting dermatologists and regulators in monitoring component safety. The move is intended to avoid confusion, improve compliance, and increase the marketability of safe products.
Source: bit.ly/3L6jz6J

A Super Speciality Hospital and one of its doctors were ordered by the State Consumer Disputes Redressal Commission (SCDRC) to compensate its patients for medical negligence. The reason for the directive was that the specialist doctor had given his responsibility to a junior and neglected to attend to the patient, which led to an incorrect diagnosis and treatment, which constituted medical misconduct.
Source: bit.ly/3zrpKQn

The Central Drugs Standard Control Organization has ordered the closure of more than 36% of the 400 drug manufacturing facilities located throughout India after an increase in inspection following deaths associated with substandard cough syrups.
Source: bit.ly/4eKMs5Y

In an effort to regulate false and misleading nutritional claims and health claims made by e-commerce platforms, the Food Safety and Standards Authority of India (FSSAI) is planning to impose stricter controls on advertisement and sale of protein supplements and shakes in India.
Source: bit.ly/45KzjpF

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

NOC for the manufacture of unapproved drugs meant for export will be issued by the Central Drug Regulator
India’s Central Drug Regulator (CDSCO) will be the competent authority to issue the No Objection Certificate (NOC) required by pharmaceutical companies for the manufacture of unapproved, new, or banned drugs for export purposes, starting from 15th May 2024. The NOC will be issued by the zonal offices of CDSCO. The application for NOC will have to be made online. Prior to CDSCO, it was the State Licensing Authorities that issued NOCs.
Source: bit.ly/4dkZO8u

Producers of Batteries can meet EPR Targets and file Annual Returns by June 30, 2024
The deadline for meeting Extended Producer Responsibility (EPR) targets and submitting annual returns by the producers of all types of batteries has been extended to June 30, 2024.
Source: bit.ly/4a0Uynx

Private hospitals demand payment of interests from the government on delay of reimbursement for treatment under Ayushman Bharat Scheme
India’s Association of Healthcare Providers (AHPI) has raised concerns over inordinate delay in receiving reimbursement for treatment provided to Ayushman Bharat beneficiaries, which impedes cash flow and poses serious operational issues for all hospitals. The Association has urged that the government pay 1 percent interest on payments delayed beyond one month under the Ayushman Bharat scheme, which is the Central Government’s flagship universal health coverage scheme, as well as change of package rate to allow beneficiaries to avail of continued benefits from the Ayushman Bharat Scheme
Source: bit.ly/3wimXHQ

US government likely to ease restrictions on regulation of Marijuana
The U.S. Drug Enforcement Administration (DEA) is likely to reclassify marijuana as a less dangerous drug by moving it from a tightly regulated class to a less tightly regulated class. Although the DEA’s proposal would highlight the medical benefits of cannabis, it would not allow its use for recreational purposes. The White House Office of Management and Budget is reportedly still in the process of reviewing the idea.
Source: bit.ly/4a2osrm

Form 483 notice need not to be responded by manufacturers of medical devices within 15 days: US Medical device experts
According to US Food and Drug Administration (FDA) officials, a medical device manufacturing company is not required to respond to a Form 483 notice (Notice of Inspectional Observations) within 15 days. The 15-day deadline for response applies to warning letters and not to Form 483 notices, though the FDA advises that if the manufacturer wishes to respond to a Form 483 notice, then it should do so within 15 days of the notice.
Source: bit.ly/44FHVxn

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Indian Drug Manufacturers will have to put in place prompt and effective recall procedure soon
At a meeting called by India’s Health Ministry with drug manufacturers, the Ministry has reportedly reminded all drug manufacturers that they will have to put in place a prompt and effective drug recall system. Such a drug recall system is a mandatory requirement of revised Schedule M of Drugs Rules, 1945, which is scheduled to come into effect on 27th June 2024 for large enterprises, and on 27th December 2024 for small and medium scale enterprises.
Source: bit.ly/3wbgKgZ

India’s central food regulator to conduct own testing and investigation into pre-packed spices manufactured in India
India’s Central Food Regulator (FSSAI) has recently issued a statement declaring that it is currently in the process of collecting samples of fruit and vegetables, fish products and spices and culinary herbs, as part of its scheduled surveillance for salmonella and other contaminants. This statement has come in light of the recent ban by Governments of Hong Kong and Singapore on certain brands of Indian spices, on the basis that the products contained Ethylene Oxide, a known carcinogen that can cause breast cancer and lymphoma.
Source: bit.ly/3UFCXgH

Supreme Court seeks explanation from Central Government on proposal to fix prices for ophthalmologic procedures
The Supreme Court has issued a Notice to the Central Government, seeking response on the nature of power and viability of regulations that permit government to uniformly fix the prices across private hospitals for Ophthalmologic procedures. The Court has clubbed this matter along with a pending case, where the Central Government has been directed by the Supreme Court to determine a policy to fix uniform prices for procedures done at private hospitals.
Source: bit.ly/4bzRdx9

If husband is unable to contribute gamete, then wife is not barred from seeking gamete from a donor for IVF: High Court
In a recent decision, the Calcutta High Court has held that, under India’s current regulatory regime surrounding In-Vitro Fertilization (IVF), there is no restriction that requires that either the egg or the sperm must come from the couple seeking the IVF themselves. A married woman may seek to obtain sperm from a third party donor.
Source: bit.ly/3Uocq68

Excessive prescription and use of Antibacterial medicine in treatment of COVID-19 has increased global Antimicrobial Resistance: WHO
The World Health Organization has recently posted findings from its Global Clinical Platform for COVID-19, which are an anonymized repository of worldwide treatment data. These findings have revealed that there has been rampant over-prescription and use of antibiotics worldwide, in the course of treating COVID-19, which has contributed to the globally rising Antimicrobial Resistance problem.
Source: bit.ly/4dnzWcb

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

New Framework to be created to separately regulate prices of Medical Devices
In response to demands from industry associations, India’s Central Drug Price Regulator, the National Pharmaceutical Pricing Authority (NPPA), in collaboration with the Department of Pharmaceuticals is reportedly in the process of developing a special pricing framework for Medical Devices comparable to similar prevailing regulations in other jurisdictions.
Source: bit.ly/49Wh8hc

Testing Standards for stability testing of In-Vitro Diagnostic Medical Devices have been prescribed to obtain manufacturing/ import license
India’s Central Drugs Standards Regulator (CDSCO) has released a draft Guideline regarding conduct of Stability Studies for In-Vitro Diagnostic Medical Devices (IvDMD). These guidelines cover the standards and testing for determining the overall shelf life, individual component stability, stability during transportation as well as, in-use stability of IvDMD. These guidelines are applicable for all manufacturers who are in preparation of submitting a pre-market review document in pursuance of obtaining a manufacturing/ import license under the Medical Devices Rules, 2017.
Source: bit.ly/4aP4TUJ

Students pursuing courses in Indian System of medicine will have to give exit test prior to applying for Registration as a practitioner of Indian System of Medicine: Delhi HC
In a recent decision, the Delhi High Court has held that only those students that have already obtained their respective recognized qualifications (either a BAMS, or BUMS degree) would be permitted to initiate the process for registering as a practitioner of Indian Traditional Medicine. This decision was taken on the basis of Sec. 15(1) of the National Commission for Indian School of Medicine Act, 2020 which mandates a common final exit test to be cleared prior to registration with State Register.
Source: bit.ly/3JxjPLo

Government relaxes obligation of deductees to pay higher TDS for persons whose PAN remained inactive for FY 2023-2024
In pursuance of Circular No. 3 of 2023, a person whose PAN (Permanent Account Number) has become inoperative has been subject to a higher rate of TDS. The Central Board of Direct Taxes has issued a notification recently, which relaxes this obligation of persons to deduct at a higher rate of TDS, for all transactions dated till 31st March 2024 provided that the linked PAN is reactivated before 31st May 2024.
Source: bit.ly/4aR96HE

AI Taking up more of Doctors’ time since it needs more training and monitoring
In a set of recently published studies at various teaching hospitals, it was revealed that using AI to manage patient interaction and medical records to assist Doctors has in fact, lead to Doctors spending more time on the tasks delegated to the AI, since the Doctors were now required to train and supervise the AI in addition to carrying out their regular responsibilities for these tasks.
Source: bit.ly/3Wg75QU

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Draft Guidance on Vaccine Approval and Quality Monitoring at port of Import published by Central Drug Regulator for Public Commect
The Central Government has recently published a draft of guidance on (1) regulatory framework for conducting vaccine related clinical trials, marketing approval, manufacture, import/ export and post marketing assessment and (2) Risk Based Approach for monitoring quality of imported drugs, medical devices and IVDs at customs ports. Public Comment is sought on these above Guidance Notes, within 30 days of publication i.e. by 10th May 2024.
Source: bit.ly/3xIoiIv
Source: bit.ly/4cVOpvL

Merchants Association Request Central Government Intervention to Stabilize trade of Medicines and Medical Devices with Africa
The Federation of Pharmaceutical and Allied Products Merchant Exporters, an industry association of small and medium sized importers and exporters, has advocated for fiscal and trade policy intervention including continued efforts to stabilize Rupee value, by the Government to stabilize the export of Medicine and Medical Products to Africa, which has seen a sharp decline due to rising shipping tariffs caused by ongoing geopolitical conflicts.
Source: bit.ly/3Q8qlvT

Threefold Increase in FDI in Healthcare and Medical Device Sector in India during latter half of FY 2023-2024
Foreign Direct Investment (FDI) into the Hospital and Diagnostic Sectors in the country has increased by about 90% in the last quarter of 2023-24, as compared to the same quarter the previous year. Moreover, the Medical and Surgical Implements Sector has also seen a nearly 1/3rd growth by proportion during the same time. The total FDI received in hospital and medical devices sector stood at USD 462 Million.
Source: bit.ly/3U6Km70

Modern medicine Doctor body Expresses Concerns regarding Introduction of Integraded School of Medicine as Treatment
The Indian Medical Association, a professional representative body of Doctors, has expressed its concerns regarding the proposal of the Central Government to institute Integrated Medicine, which would offer treatments which are a mix of allopathic, homeopathic and traditional medicine. The Council expressed concern that due to the vast gulf in the manner of training, specialization and expertise between the various schools of medicine means that integration and cross practice treatment may pose severe risk to patient.
Source: bit.ly/3U6yi5E

EU and Japan harmonize Pharmacopoeia for ease of doing Business and regulatory Burden
The European Directorate for the Quality of Medicine and Healthcare, and the Japanese Ministry of Health, Labour and Welfare have entered into a Memorandum of Cooperation and Confidentiality, to coordinate efforts to harmonize the European and Japanese Pharmacopoeia, a move that would reduce the regulatory burden on manufacturers operating in the twin jurisdictions, with respect to carrying out compendial tests and IP approval.
Source: bit.ly/3UmRBJo

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E-Commerce websites instructed to avoid marketing Milk/ cereal/ malt based drinks as “Energy Drinks”
India’s Food Standards Regulator (the Food Safety Standards Authority of India) has issued an advisory to e-commerce websites, requiring them to ensure that proprietary foods, i.e. foods that are not categorized under the Food Standards Regulations, specifically those currently registered as analogues to milk/ cereal/ malt based beverage, should not be advertised as “Health Drink”/ “Energy Drink”, as only carbonated/ non-carbonated water-based flavoured drinks are regulated as “Health Drink” and “Energy Drink”.
Source: bit.ly/3xlfzvD

Drug Price Regulator may examine prevalent drug substitution and discounting prices offered by major drug retail stores in India
The Indian Central Drugs Regulator (CDSCO) has reportedly requested the Central Drugs Price Regulatory Body (NPPA) to investigate drug substitution and discounting practices of a major pharmacy chain on the basis a complaint raised by State Chemists and Druggists’ Association of the State of Karnataka (KCDA). In its complaint, the KCDA has alleged that the major pharmacy chain has been deliberately undercutting prices, sustained by substitution of prescribed drugs with other cheaper but identical formulations and unreasonably increasing its profit margins, which is currently violative of regulations applicable to pharmacists, as well as pricing norms of drugs.
Source: bit.ly/4cJSJOg

Vaccine manufacturers may have to provide manufacturing and sales data to government soon
The advisory body to India’s Central Drugs Regulator, the Drugs Consultative Committee, has requested various State-level Drug Licensing Authorities to ensure submission of details of the manufacture and sale of vaccines within the states to the Central Drugs regulator (Central Drugs Standards Control Organization), for the purpose of meeting obligation for the Global Benchmarking of Vaccines of the World Health Organization.
Source: bit.ly/3PJkAEw

Major Ayurvedic Medicine manufacturer may be on hook for contempt of court after Supreme Court rejects its apology for publishing misleading advertisements
In its ongoing proceedings against a major Ayurvedic medicine manufacturer for publication of misleading advertisements in contravention of undertaking given by it to the Supreme Court, the Court has refused to accept the apology which was tendered by the manufacturer, and rejected submissions of the manufacturer that: (1) The restriction on advertisement under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 is archaic and may be relaxed since the manufacturer now has scientific data to back its claims, and (2) that the manufacturer should not be held liable for an advertisement issued by an independent marketing department.
Source: bit.ly/4akJen5

Australia updates Medical Device Recall Procedure
The Australian Therapeutics Goods Administration, which regulates medical devices at the central level in the country, has published a revised version of the Uniform Recall Procedure for Therapeutic Goods (URPTG), which relaxes regulatory burden of importers and manufacturers of medical devices. The revised URPTG provides additional clarity on procedure for immediate recall, clarifying timing of release of recall information by the regulator, modifying Customer Response Forms, and eases the filing requirements under the law by making all templates for recall action publicly available on the website of regulator.
Source: bit.ly/3TAZJEo

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Periodic Safety Update Reports for Medical Devices to be filed only through online portal of CDSCO
The Central Medical Devices Regulator of India (Central Drugs Standards Control Organization) has issued a circular, stating that starting on 1st April 2024 it will require and restrict all manufacturers of Medical Devices/ In-vitro Devices to make submission of Periodic Safety Update Reports, only on the online portal and that offline mode of submission of application will not be accepted going forward.
Source: bit.ly/3TEO74B

Absence of Regulation of Second-Hand Medical Devices being Imported into India flagged by Parliamentary Panel
The Department-related Parliamentary Standing Committee on Chemicals and Fertilisers, in a recent report, has highlighted that currently India’s Central Medical Device Regulations (Medical Devices Rules, 2017) do not regulate second-hand medical devices. The Committee has recommended framing policy to ensure its quality and safety, as well as introducing possible restrictions on import of second-hand or refurbished Medical Devices into India.
Source: bit.ly/3VsdCaQ

Supreme Court Orders Director of Company as well as Endorser of offending Advertisement to be present for Contempt Proceedings relating to misleading advertisements
As part of the ongoing action being taken against a major Indian Ayurvedic Medicine manufacturer for publication of misleading advertisements regarding its products in contravention of an undertaking provided to the Court, the Supreme Court, in pursuance of determining whether to pursue contempt proceedings against the manufacturer, has issued an order requiring the physical presence of the Director of the entity as well as a prominent Ayurvedic Yoga practitioner who had given his endorsement to the claims made in the offending advertisements of the Company.
Source: bit.ly/3vu45VQ

Delhi High Court orders suspension of accounts accused of impersonation of prominent investment group despite objection that no evidence of involvement is provided.
In pursuance of ongoing action against certain anonymous persons impersonating a prominent Investment group and misleading the general public, the Delhi High Court has issued a further order to messaging platform WhatsApp to take action to remove/ block access to certain accounts/ messaging groups, despite objection from the platform that the account/ messaging groups have been prove to neither violate T&Cs of WhatsApp, nor having carried out any illegal activity.
Source: bit.ly/3vkn7hu

EU Parliamentary Committee votes to present amendment to increase exclusivity period for orphan drugs and introduce extended regulatory data-protection period.
The European Parliamentary Committee on Environment, Public Health and Food Safety has voted in favour of introducing several amendments to the current EU Pharmaceutical Directive, including a controversial proposal to increase the exclusivity period for Orphan Drugs from 10 to 11 years, as well as an extended regulatory data-protection period of 9 years; both decisions that industry experts believe may have adverse consequences for competition in the EU Pharmaceutical Market.
Source: bit.ly/3Vr9zeK

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

State Consumer Commissions continue to dilute intermediary safe-harbour protection for e-commerce marketplace
A State Consumer Commission in India has held a major e-commerce marketplace company liable for delivery of incorrect goods to customers, on the grounds that since it offered a ‘fulfilling’ service on behalf of the seller, it was not merely an intermediary but also an agent of the seller. The marketplace was made to pay punitive damages, in addition to mental harassment, on grounds that it may have unscrupulously exploited an unknown uncounted number of consumers.
Source: bit.ly/49VuNW0

Kochi and Thiruvananthapuram proposed to be added to the list of airports from where drugs may be imported
India’s Ministry of Health and Family Welfare has issued a draft notification that will add Kochi and Thiruvananthapuram to the list of airports from which pharmaceutical drugs may be imported into India. The Drugs Rules, 1945 specify that pharmaceutical drugs may be imported into India from a specified number of airports only. The clearance of drugs requires the approval of the Additional Drugs Controller (ADC) Customs, who is generally posted at the customs wing of the airport.
Source: bit.ly/49zbUZ8

Dengue Vaccine Clinical Trials to start soon in India
A major Japanese drug maker has reportedly received clearance from India’s vaccine regulator, Central Drugs Standards Control Organization, to start clinical trials of the dengue vaccine. The vaccine will be contract manufactured by a major biotech company in India.
Source: bit.ly/49OyQ7b

Many medical device companies settled allegations of kickbacks given to doctors in 2023: US Department of Justice
The US Department of Justice (DoJ) has issued a press release that it has recorded the highest number of settlements and judgements in its history. Some of major settlements involved allegations of unlawful kickbacks medical device companies to doctors, in form of above-fair market value supervision fees or remuneration for medical directorships and improper donation of capital equipment.
Source: bit.ly/49X0H4H

Fair-use defense against copyright infringement by AI companies will be tested in new trial by media companies against Open AI
In a new set of lawsuits in the US, media companies are not alleging copyright infringement by AI companies to train the algorithm, but instead alleging that before training, the AI companies removed information from the training material which established that the material was copyrighted, such as the name of the author the news. The Digital Millennium Copyright Act or DMCA, law in the US reportedly prohibits the removal of information that can help copyright holders detect infringement, including article titles, author names, and copyright dates.
Source: bit.ly/3Ih1MbA

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Guidelines to differentiate brand extension from surrogate advertising issued
In a meeting with stakeholders, the Department of Consumer Affairs (DoCA) has clarified the difference between brand extension advertisements which are permitted, and surrogate advertisements which are not permitted. A brand extension advertisement should not contain direct or indirect references to prohibited products. It should also not use colour, layout, or presentations associated with the prohibited products.
Source: bit.ly/42PKVGk

Draft Pharmacovigilance Guidance Document published for comments
A draft of the revised Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products has been published for comments. The last date for providing comments is March 23, 2024. This guidance document facilitates MAHs to setup & implementation of uniform Pharmacovigilance System for pharmaceutical products in the Indian market in the post-licensure period.
Source: bit.ly/3SSrfgw

Many small and medium pharmaceutical manufacturing units have been ordered shut down after increased surveillance
India’s central drug regulator, Central Drugs and Standards Control Organization (CDSCO), and state-level drug licensing authorities have reportedly issued show-cause notices to several drug small and medium manufacturers in the State of Punjab and Himachal Pradesh on grounds of poor quality control, and have also directed some of them to stop manufacturing.
Source: bit.ly/3I88UqP

Pharma MNCs exit domestic market due to regulatory headwinds
Many multinational pharmaceutical companies are reportedly cutting back on operations and manufacturing in India as part of a global strategic review due to regulatory headwinds on account of price control, rising costs, competition, and unfavourable intellectual property climate.
Source: bit.ly/42PaWW9

Frozen embryos should be treated as children: US Court
The Alabama State Supreme Court has ruled that frozen embryos in test tubes should be treated as ‘children’. This ruling has forced in vitro fertilization (IVF) providers in Alabama to stop treating patients, raising questions about the procedure’s continued availability in the state.
Source: bit.ly/3I8T4vR

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New NSWS Portal to obtain permission to import and manufacture new drugs for use in Clinical Trials in India

The India’s Central Drugs and Clinical Trial Regulator, The Central Drugs Standard Control Organization (CDSCO), has issued a public notice that it will no longer accept application for grant of permission to import or manufacture new drugs, unapproved active pharmaceutical ingredients (APIs) of new drugs, or investigational new drugs, which are to be used in laboratory tests or analysis or in domestic or global clinical trials conducted in India. Such applications, from 16th January 2024, will have to be made through the National Single Window System (NSWS) portal only.

What is NSWS portal?

The NSWS portal is a digital platform established by the Indian Government with the aim to act as a single window for all the approvals. The portal enables the investors (manufacturers, importers, traders etc.) to obtain registrations and approvals according to their business requirements.

Which applications for permission in relation to clinical trials will be accepted through the NSWS portal only?

From 16th January 2024, the below mentioned applications in relation to import and manufacture of unapproved APIs, new drugs and investigational new drugs will have to be filed through NSWS portal only:

  • Application for grant of permission to manufacture new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis (Form CT-10).
  • Application for grant of permission to manufacture formulation of unapproved active pharmaceutical ingredient for test or analysis or clinical trial or bioavailability or bioequivalence study (Form CT-12).
  • Application for grant of permission to manufacture unapproved active pharmaceutical ingredient for development of formulation for test or analysis or clinical trial or bioavailability or bioequivalence study (Form CT-13).
  • Application for grant of licence to import new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis (Form CT-16).
  • Also, an application for licence to import drugs for purpose of examination, test or analysis (Form-12) was also made live on NSWS portal from 24th January, 2024.

What will happen to the applications that were already filed on Sugam portal before 16th January 2024?

The above-mentioned applications that were filed on the Sugam portal will be processed through that portal only. Any new application post 16th January 2024 should be filed through NSWS portal only. The Sugam portal will be disabled for the filing of these applications after 10th February 2024

Is there any official guidance available to ease the new filings through NSWS portal?

A user guide for the filing of application through NSWS portal for the above-mentioned regulatory approvals is made available along with the notice.

What are the other applications which may be made through NSWS Portal?

On 1st January 2024, CDSCO issued a notice that certain medical device regulatory applications, including application for permission to import or manufacture medical device for clinical investigations, will not be accepted on the current medical device CDSCO portal (CDSCO MD-Online portal) after 15th January 2024. Instead, such applications will be accepted through the NSWS portal only.

For more details, please refer our article which covers this update: New portal for medical devices registration in India (NSWS)

Conclusion:

Sponsors of clinical trials, clinical research organizations (CROs), and various drug testing and analytical laboratories in India, which import unapproved APIs for testing and analysis, or for use in clinical trials, should take note of this very important development, in order to avoid any surprise which may impact the drug development and clinical trial timelines.

At a high-level, it is now clear that, in near future, CDSCO will transition all application forms for all pharmaceutical and medical device licenses and permissions to NSWS.